nal von minden NADAL COVID-19 IgG Instructions D'utilisation page 7

ENGLISH
 The test kit contains products of animal origin. Certified
knowledge of the origin and/or sanitary state of the animals
does not completely guarantee the absence of transmissible
pathogenic agents. It is therefore recommended that these
products be treated as potentially infectious and handled in
accordance with usual safety precautions (e.g., do not
ingest or inhale).
 Temperature can adversely affect test results.
 Failure to bring specimens and reagents to room
temperature prior to testing may decrease assay sensitivity.
Inaccurate or inappropriate specimen collection, storage or
transport may yield false negative test results.
 Used testing materials should be disposed of according to
local regulations.
8. Specimen Collection and Preparation
The NADAL® COVID-19 IgG/IgM Test can be performed using
whole blood (from venipuncture or fingerstick), serum or
plasma.
To collect fingerstick whole blood specimens:
 Wash the patient's hand with soap and warm water or
clean it with an alcohol pad. Allow it to dry.
 Massage the hand, without touching the puncture site, by
rubbing along the hand towards the fingertip of the middle
or ring finger.
 Puncture the skin with a sterile lancet, Wipe away the first
drop of blood.
 Gently rub the hand from the wrist to the palm, and then to
the finger to form a rounded drop of blood over the
puncture site.
Fingerstick whole blood should be tested immediately.
Venipuncture whole blood specimens
Containers containing anticoagulants, such as EDTA, citrate,
heparin or oxalate should be used for the preparation of
venous whole blood or plasma specimens.
Testing should be performed immediately after specimen
collection. Do not leave specimens at room temperature for
prolonged periods of time.
If the test is to be run within 3 days of specimen collection,
whole blood collected by venipuncture should be stored
at 2-8°C.
Do not freeze whole blood specimens.
Serum and plasma specimens
Separate serum or plasma from blood as soon as possible to
avoid haemolysis, Use only clear, non-haemolysed specimens.
Testing should be performed immediately after specimen
collection. Do not leave specimens at room temperature for
prolonged periods of time. Serum and plasma specimens can
be stored at 2-8°C for up to 7 days. For long-term storage,
specimens should be kept at -20°C.
Bring specimens to room temperature prior to testing. Frozen
specimens should be completely thawed and mixed well prior
to testing. Specimens should not be frozen and thawed
repeatedly.
nal von minden GmbH • Carl-Zeiss-Strasse 12 • 47445 Moers • Germany • info@nal-vonminden.com • www.nal-vonminden.com
NADAL® COVID-19 IgG/IgM Test
(Ref. 243003N-25)
If specimens are to be shipped, they should be packed in
compliance with all applicable
transportation of etiologic agents.
Icteric, lipemic, haemolysed, heat-treated and contaminated
specimens may lead to inaccurate test results.
9. Test Procedure
Bring tests, specimens, buffer and/or controls to room
temperature (15-30°C) prior to testing.
1. Remove the test cassette from the foil pouch and use it as
soon as possible. The best results will be obtained if the
test is performed immediately after opening the foil
pouch. Label the test cassette with the patient or control
identification.
2. Place the test cassette on a clean
and level surface.
3. a) For serum or plasma specimens:
Holding the pipette vertically, draw
the specimen up to the first
widening (approximately 5 μL) and
add it to the specimen well (S) of the
test cassette.
b) For venipuncture whole blood
specimens:
Holding the pipette vertically, add
1 drop (approximately 10 μL) of a
whole blood specimen to the
specimen well (S) of the test
cassette.
4. Holding the buffer bottle vertically,
add 2 drops of buffer to the
specimen well (S). Avoid air bubbles
forming.
5. Start the timer.
6. Wait for the red line(s) to appear.
Read the test result after exactly 15
minutes. Do not interpret the result
after more than 15 minutes.
10. Result Interpretation
Positive for IgM
The blue line in the control line
region 'C' turns red. Another
red line develops in the test line
region 'IgM'.
Positive for IgG
The blue line in the control line
region 'C' turns red. Another
red line develops in the test line
region 'IgG'.
Positive for IgG and IgM
The blue line in the control line
region 'C' turns red. A red line
develops in the test line region
'IgM' and another one develops
in the test line region 'IgG'.
regulations for the
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